Method for replacing a tricuspid valve

ABSTRACT

A method of implanting a prosthetic heart valve at a native tricuspid valve region includes delivering a prosthetic heart valve to the native tricuspid valve region via the inferior vena cava or the superior vena cava and deploying the prosthetic heart valve from a sheath of a delivery apparatus. The prosthetic heart valve includes a radially compressible and expandable frame assembly having an inflow end, an outflow end, and a double-body structure having an annular inner frame and an annular outer frame. The outer frame preferably includes an atrial flange portion configured to contact an atrial face of the native tricuspid valve region. The prosthetic heart valve can further include a plurality of ventricular anchors, each comprising a free end portion and a fixed end portion connected to and extending from the frame assembly at a location spaced from the outflow end of the frame assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/902,773, filed Jun. 16, 2020, which is a continuation of U.S. patentapplication Ser. No. 16/015,003, filed Jun. 21, 2018, now U.S. Pat. No.10,687,939, which is a continuation of U.S. application Ser. No.15/382,429, filed on Dec. 16, 2016, now U.S. Pat. No. 10,010,414, whichis a continuation of U.S. application Ser. No. 14/730,639, filed on Jun.4, 2015, now U.S. Pat. No. 9,532,870, which claims the benefit of U.S.Provisional Application No. 62/009,072, filed Jun. 6, 2014. The priorapplications are incorporated herein by reference in their entirety.

FIELD

This disclosure pertains generally to prosthetic devices for repairingand/or replacing native heart valves, and in particular to prostheticvalves for replacing defective mitral valves, as well as methods anddevices for delivering and implanting the same within a human heart.

BACKGROUND

Prosthetic valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (i.e., the aortic,pulmonary, tricuspid, and mitral valves) serve critical functions inassuring the forward flow of an adequate supply of blood through thecardiovascular system. These heart valves can be rendered less effectiveby congenital malformations, inflammatory processes, infectiousconditions, or disease. Such damage to the valves can result in seriouscardiovascular compromise or death. For many years the definitivetreatment for such disorders was the surgical repair or replacement ofthe valve during open-heart surgery. Such surgeries are highly invasiveand are prone to many complications, however. Therefore, elderly andfrail patients with defective heart valves often go untreated. Morerecently a transvascular technique has been developed for introducingand implanting a prosthetic heart valve using a flexible catheter in amanner that is much less invasive than open-heart surgery.

In this technique, a prosthetic valve is mounted in a crimped state onthe end portion of a flexible catheter and advanced through a bloodvessel of the patient until the prosthetic valve reaches theimplantation site. The prosthetic valve at the catheter tip is thenexpanded to its functional size at the site of the defective nativevalve, such as by inflating a balloon on which the prosthetic valve ismounted.

Another known technique for implanting a prosthetic aortic valve is atransapical approach where a small incision is made in the chest wall ofa patient and the catheter is advanced through the apex (i.e., bottomtip) of the heart. Like the transvascular approach, the transapicalapproach can include a balloon catheter having a steering mechanism fordelivering a balloon-expandable prosthetic heart valve through anintroducer to the aortic annulus. The balloon catheter can include adeflectable segment just proximal to the distal balloon to facilitatepositioning of the prosthetic heart valve in the proper orientationwithin the aortic annulus.

The above techniques and others have provided numerous options for highoperative risk patients with aortic valve disease to avoid theconsequences of open heart surgery and cardiopulmonary bypass. Whiledevices and procedures for the aortic valve are well-developed, suchcatheter-based procedures are not necessarily applicable to the mitralvalve due to the distinct differences between the aortic and mitralvalve. The mitral valve has a complex subvalvular apparatus, e.g., thechordae tendineae and papillary muscles, which is not present in theaortic valve.

Surgical mitral valve repair techniques (e.g., mitral annuloplasty) haveincreased in popularity due to their high success rates, and clinicalimprovements after repair. In addition to existing mitral valve repairtechnologies, there are a number of new technologies aimed at makingmitral valve repair a less invasive procedure. These technologies rangefrom iterations of the Alfieri stitch procedure, to coronary-sinus-basedmodifications of mitral anatomy, to subvalvular plications orventricular remodeling devices, which would incidentally correct mitralregurgitation.

However, for mitral valve replacement, few less-invasive options areavailable. There are approximately 25,000 mitral valve replacements(MVR) each year in the United States. However, it is estimated that over300,000 patients meeting the guidelines for treatment are deniedtreatment based on their ages and/or co-morbidities. Thus, a need existsfor minimally invasive techniques for replacing the mitral valve.

In particular, a need exists for minimally invasive techniques withenhanced ease of implantation and reduced risk of misplacement due tooperator error or biological variability. Specifically, a need existsfor prosthetic heart valves that can be deployed within the valveannulus and that do not require a particular angular alignment. A needalso exists for prosthetic heart valves that can move synchronously withthe native valve annulus.

SUMMARY

In one representative embodiment, a prosthetic device is provided forimplanting at a native mitral or tricuspid valve region of the heart,the native valve region having a native valve annulus and nativeleaflets. The prosthetic device can comprise a main body configured forplacement within the native mitral valve annulus, the main body having alumen extending between an atrial end and a ventricular end. Theprosthetic device can also have an atrial cap extending radiallyoutwardly from the atrial end of the main body. The prosthetic devicecan also have a plurality of ventricular anchors spaced angularly arounda circumference of the main body. Each ventricular anchor can have aproximal end portion connected to the main body at locations proximatethe ventricular end, an intermediate portion extending away from theatrial end and then back toward the atrial end so as to define a firstbend, and a free distal end portion that extends from the intermediateportion, the distal end portion comprising a first section, a secondsection, and a second bend between the first and second sections, thefirst section extending from the intermediate portion in a directiontoward the atrial end and radially away from the main body.

In some embodiments, at least one of the ventricular anchors of theprosthetic device comprises a pattern of repeating turns (such as aserpentine pattern).

In some embodiments, the atrial cap comprises a plurality of angularlyspaced atrial anchors, each having a proximal end portion connected tothe atrial end of the main body and a distal end portion extendinggenerally downwardly toward the ventricular end.

In some embodiments, the proximal end portions of the atrial anchorsproject upward into the atrium and curved intermediate portions of theatrial anchors connect the proximal end portions to the distal endportions.

In some embodiments, the atrial cap blocks blood from flowing beyond theatrial end of the main body, along the outside of the main body, whenthe prosthetic device is implanted.

In some embodiments, the main body is radially compressible to aradially compressed state for delivery into the heart and canself-expand from the compressed state to a radially expanded state.

In some embodiments, in a radially compressed state, each ventricularanchor is linearly extended, such that the proximal end portions anddistal end portions are axially aligned, parallel to the axis of themain body.

In some embodiments, the plurality of ventricular anchors is connectedto the main body independently of each other without frame segmentsinterconnecting adjacent ventricular anchors.

In some embodiments, the free end portions of the ventricular anchorseach comprise a curved or rounded element.

In some embodiments, the plurality of atrial anchors is connected to themain body independently of each other without frame segmentsinterconnecting adjacent atrial anchors.

In some embodiments, the first sections of the distal end portions ofthe ventricular anchors extend away from a longitudinal axis of the mainbody and the second sections of the distal end portions extendsubstantially parallel to the longitudinal axis.

In some embodiments, the second sections of the distal end portionscurve toward the atrial end and back toward the ventricular end of themain body.

In some embodiments, the atrial anchors have varying lengths and/or theventricular anchors have varying lengths.

In some embodiments, the ventricular anchors can be connected to theventricular end of the main body.

In some embodiments, the ventricular anchors can be connected to themain body at locations spaced from the ventricular end of the main body.

In another representative embodiment, a prosthetic device can have amain body and an atrial cap extending radially outward from the atrialend of the main body. When released from a delivery sheath, the atrialcap can transform from a radially compressed, cylindrical shapeextending from the atrial end of the main body to a deployed state inwhich the atrial cap extends radially outward and curls below the atrialend toward the ventricular end of the main body.

In some embodiments, the prosthetic device can have a plurality ofventricular anchors extending from the ventricular end of the main body.

In some embodiments, the main body can have a cylindrical inlet portiondefining an inlet diameter of the main body and a tapered outlet portiondefining an outlet diameter of the main body, wherein the outletdiameter is smaller than the inlet diameter.

In some embodiments, the ventricular anchors can have curved portionsthat extend away from the ventricular end of the main body and curveback toward the atrial end of the main body, wherein the curved portionshave a reduced thickness relative to the remaining portions of theanchors.

In another representative embodiment, a method is provided forimplanting a prosthetic heart valve at a native atrioventricular valveregion having a native valve annulus and a plurality of native leaflets.The method can comprise providing a transcatheter prosthetic heart valvecontained within an interior of a sheath of a delivery apparatus,wherein the prosthetic heart valve comprises an annular main body and aplurality of ventricular anchors extending from the main body, theventricular anchors being connected to the main body independently ofeach other without frame segments interconnecting adjacent anchors. Themethod can further comprise delivering the prosthetic device to thenative valve region and deploying the prosthetic heart valve from thesheath such that the main body expands within the native annulus and theplurality of ventricular anchors extend behind the native leaflets. Eachventricular anchor has a proximal end portion extending in a directionaway from the atrial end of the main body, an intermediate portionextending back toward the atrial end, and a distal end portion extendingtoward the atrial end and radially away from the main body.

In some embodiments, the native valve annulus is the mitral valveannulus and the prosthetic heart valve is delivered to the annulus viathe left atrium.

In some embodiments, a distal end portion of one or more of theplurality of ventricular anchors projects upward to contact aventricular surface of the native valve annulus.

In some embodiments, the method further comprises wrapping one or moreof the ventricular anchors behind the native leaflets.

In some embodiments, delivering the prosthetic valve comprisestransporting the prosthetic heart valve across the atrial septum intothe left atrium.

In some embodiments, deployment of the main body causes the distal endportions of the ventricular anchors to rotate toward the main body.

In some embodiments, following deployment, the prosthetic valve and thenative valve annulus move in a generally synchronous manner duringcardiac cycling.

In some embodiments, the method further comprises advancing the outersheath distally to recapture the plurality of ventricular anchors withinthe interior of the outer sheath.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a side schematic view of an exemplary prosthetic valve,according to one embodiment.

FIG. 1B is a side schematic view of another exemplary prosthetic valve.

FIG. 2 is a top schematic view of the prosthetic valve of FIG. 1A orFIG. 1B.

FIGS. 3A-3C are side schematic views of three bare frames for use in aprosthetic valve, which illustrate three exemplary methods formanufacturing and shaping a frame according to the present disclosure.

FIG. 4 is a top-sided perspective view of an exemplary frame for use ina prosthetic valve.

FIG. 5 is a bottom-sided perspective view of another exemplary frame foruse in a prosthetic valve.

FIGS. 6A-6C show three exemplary ventricular anchors for use in aprosthetic valve, each featuring a repeating pattern of turns. FIG. 6Ashows a ventricular anchor having a pattern of coils. FIG. 6B shows aventricular anchor having a serpentine pattern. FIG. 6C shows aventricular anchor having a helical pattern.

FIG. 7 is a top-sided perspective view of another exemplary frame foruse in a prosthetic valve.

FIG. 8 is a bottom-sided perspective view of the prosthetic valve ofFIG. 7 .

FIG. 9 is a side view of another exemplary frame for use in a prostheticvalve, with a single atrial anchor and a corresponding ventricularanchor shown in a deployed configuration for purposes of illustration.The remaining atrial and ventricular anchors are shown in anon-deployed, delivery configuration. FIG. 9A is an enlarged view of theatrial anchor and the ventricular anchor that are shown in the deployedconfiguration in FIG. 9 .

FIG. 10 is a side schematic view of another exemplary frame for use in aprosthetic valve, with a single atrial anchor and a correspondingventricular anchor shown in a deployed configuration for purposes ofclarity. The remaining atrial and ventricular anchors are shown in anon-deployed, delivery configuration.

FIG. 11 is a top-sided perspective view of another exemplary frame foruse in a prosthetic valve.

FIG. 12 is a bottom-sided perspective view of the prosthetic valve ofFIG. 11 .

FIG. 13 is a top view of another exemplary prosthetic valve with anatrial cap having serpentine arms.

FIG. 14 is a top view of another exemplary prosthetic valve with anatrial cap having a combination of serpentine arms and non-serpentinearms.

FIGS. 15A-15C show an exemplary method for deploying a prosthetic valvefrom a retractable sheath.

FIGS. 16A-16D show an exemplary method for implanting a prosthetic valveat the mitral valve annulus region via a transseptal approach.

FIG. 17 shows another exemplary method for implanting a prosthetic valveat the mitral valve annulus region, via a transatrial approach.

FIG. 18 shows another exemplary method for implanting a prosthetic valveat the mitral valve annulus region, via a transfemoral approach.

FIG. 19 shows another exemplary method for implanting a prosthetic valveat the mitral valve annulus region, via a transventricular approach.

FIG. 20 illustrates the ventricle side of a native mitral valve havingventricular anchors that engage the tissue of the native valve, creatinga seal against the outer surface of the main body of the frame. Theprosthetic leaflets and material layers are omitted for clarity ofillustration.

FIG. 21 shows a side elevation view of another exemplary embodiment of aframe for a prosthetic valve.

FIG. 22 shows a side view of a metal tube for forming the frame of FIG.21 , shown with an area of reduced thickness that forms a portion of theventricular anchors.

FIG. 23 shows the tube of FIG. 22 and a pattern for laser cutting theframe from the tube.

FIG. 24 shows a cross-sectional view of a ventricular anchor of theframe of FIG. 21 .

FIG. 25 shows a side elevation view of another exemplary embodiment of aframe for a prosthetic valve.

FIG. 26 shows the frame of FIG. 25 covered by an outer skirt.

FIG. 27 is an enlarged, perspective view of a ventricular anchor of theframe of FIG. 25 .

DETAILED DESCRIPTION Overview

When a native valve fails to function properly, a prosthetic valvereplacement can help restore the proper functionality. Compared to theaortic valve, however, which has a relatively round and firm annulus(especially in the case of aortic stenosis), the mitral valve annuluscan be relatively less firm and more unstable. Consequently, it may notbe possible to secure a prosthetic valve that is designed primarily forthe aortic valve within the native mitral valve annulus by relyingsolely on friction from the radial force of an outer surface of aprosthetic valve pressed against the native mitral annulus.

Described herein are embodiments of prosthetic valves and componentsthereof that are primarily intended to be implanted at the mitral valveregion of a human heart, as well as devices and methods for implantingthe same. The prosthetic valves can be used to help restore and/orreplace the functionality of a defective native valve. These prostheticvalves are not restricted to use at the native mitral valve annulus,however, and can be used to replace other valves within the heart, suchas the tricuspid valve, aortic valve, and pulmonary valve. In somecases, the disclosed devices can also be used to replace a venous valveor generate a valved or valveless fistula or patent foramen ovale (PFO).

In general, the prosthetic valves described herein employ an “atrialcap” and ventricular anchors instead of (or in addition to) radialfriction forces, to secure the prosthetic valve within the native valveannulus. The atrial cap can comprise a plurality of atrial anchorsspaced angularly around a circumference of the prosthetic valve. Theatrial anchors can together form an atrial sealing portion that extendsradially outward and downward, from the main body, to cover the atrialsurface of the native annulus.

FIGS. 1A, 1B and 2 illustrate the general concept for the prostheticvalve, showing two exemplary prosthetic valve embodiments 10. FIG. 1A isa side view of a first embodiment of the prosthetic valve. FIG. 1B is aside view of a second embodiment of the prosthetic valve. FIG. 2 is atop plan view applicable to both embodiments. Each prosthetic valve 10has a valve structure 4 comprising a plurality of leaflets 6, and aframe comprising a main body (which is covered by an outer skirt 12), anatrial cap member 14 extending from the inflow end of the main body, anda plurality of ventricular anchors 16 extending from the outflow end ofthe main body. The atrial cap 14 can be configured to apply a constantpressure on the atrial surface of the native valve annulus. As shown inFIG. 1B, the atrial cap 14 can be angled downwardly toward theventricular anchors to produce or to augment this pressure. In otherembodiments, as shown in FIG. 1A, the cap 14 is substantially flat andextends radially outwardly at about a 90-degree angle relative to themain body.

The atrial cap 14 can further comprise a plurality of radially-extendingsupport elements, arms, struts, or anchors 18 (FIG. 2 ). The supportelements 18 and/or the spaces in between the elements 18 can be coveredby a blood-impermeable material cover or layer 20 (e.g., a biocompatiblefabric or tissue material layer). In this manner, the atrial cap 14 canblock blood from flowing back into the left atrium between the outersurfaces of the prosthetic valve 100 and the native valve tissue duringsystole. The atrial cap can also ensure that all, or substantially all,of the blood passes through the one-way valve as it flows from the leftatrium to the left ventricle during diastole. As such, the atrial capprevents or reduces perivalvular leakage.

The skirt 12 can be connected to the inner and/or outer surfaces of themain body to form at least one layer or envelope covering some or all ofthe openings in the main body. The skirt 12 can be connected to theframe, for example, by sutures. The skirt 12 and the layer 20 cancomprise a fabric that is impermeable to blood but can allow for tissueingrowth. The skirt 12 and the layer 20 can comprise syntheticmaterials, such as polyester material or a biocompatible polymer. Oneexample of a polyester material is polyethylene terephthalate (PET).Another example is expanded polytetrafluoroethylene (ePTFE), eitheralone, or in combination at least one other material. Alternativematerials can also be used. For example, the skirt 12 and the layer 20can comprise biological matter, such as pericardia! tissue (e.g.,bovine, porcine, or equine pericardium) or other biological tissue.

In some embodiments, the atrial cap 14 can comprise a plurality ofatrial arms or anchors, which can project radially outward and/ordownward to provide an effective, atraumatic sealing configuration, asfurther described below. These atrial anchors and/or the spaces betweenthe anchors can be covered by a blood-impermeable material.

As discussed above, in the embodiment illustrated in FIG. 1B, the atrialcap 14 is angled or concave downwards. The atrial cap comprises atrialanchors 18 (FIG. 2 ) that angle downwards from an inlet end of a frame58 (FIGS. 3A-3C), forming acute angles therewith.

Some embodiments of an angled atrial cap 14 generate a downward force onthe native valve annulus, improving a compressive seal with the nativevalve annulus. Moreover, in some embodiments in which at least oneatrial anchor 18 or one group of atrial anchors is independently movableor positionable with respect to another, the atrial anchors 18 betterconform to the shape of the native valve. For example, the native mitralvalve complex, including the annulus, trigones, and leaflets, typicallyhas a saddle shape on the atrial side. Such atrial anchors 18 alsopermit the atrial cap 14 to accommodate movement of the heart tissueover the cardiac cycle. This adaptability to the shape and/or movementof the native tissue improves sealing and/or reduces perivalvularleakage in some embodiments.

The ventricular anchors 16 can be configured to extend into theventricle and to project back upward towards the native valve annulus.The ventricular anchors 16 can be spaced angularly around acircumference of a ventricular end of the prosthetic valve 10. In theillustrated embodiment, the ventricular anchors are connected to themain body of the frame independently of each other, that is, withoutadditional metal frame segments or struts interconnecting adjacentanchors. In this manner, each ventricular anchor can flex relative tothe others, as well as relative to the main body to ensure or facilitatethe anchors closely engaging adjacent tissue in the left ventricle,including the native leaflets, the trigone areas, and/or the chordaetendineae. The anchors 16 can be configured such that their distal endscontact a ventricular side of the native valve annulus and/or anadjacent tissue region (such as one or more trigone areas). Proximal endportions of the anchors 16 can extend downward from the main body intothe ventricle, intermediate portions of the anchors can wrap behind theleaflets, and distal end portions can extend upward to (optionally)contact the native annulus and/or adjacent tissue areas. One or more ofthe ventricular anchors 16 can, but need not necessarily, pin orotherwise capture a leaflet between the anchor and the main body.

In some embodiments, the individual atrial and/or ventricular anchorshave equal lengths and/or are substantially symmetrically arrangedaround the main body. In other embodiments, at least one atrial and/orventricular anchor independently has a different length and/or isasymmetrically arranged around the respective end of the main bodycompared with one or more other anchors of the same type. In some cases,the native valve annulus is asymmetrical in shape, such that havingatrial and/or ventricular anchors with non-equal lengths and/orasymmetrical arrangements is desirable. In some cases, shorter atrialand/or ventricular anchors can be placed adjacent to thinner areas ofthe atrial or ventricular septum. Additionally, the aortic valve ispositioned behind the anterior leaflet of the native mitral valve, sothe atrial anchors and/or ventricular anchors facing anteriorly (i.e.,facing the aortic valve) may be relatively shorter to avoid disruptingor otherwise interfering with the function of the aortic valve. Finally,some embodiments comprise longer ventricular anchors that project upwardto contact the native valve annulus and shorter ventricular anchors thatdo not project as far upward. In some embodiments, one or more of theshorter ventricular anchors projects upward to interact with the chordaetendineae.

In some embodiments, the individual atrial and/or ventricular anchorshave a consistent thickness along their respective lengths. In otherembodiments, one or more of the individual atrial and/or ventricularanchors have a variable thickness along its length. Varying thethickness of anchor can provide benefits with regard to strainreduction, for example, helping to reduce plastic deformation and riskof fracture. A variable thickness can also make the anchors flexible atcertain points to help reduce the stress placed on adjacent anatomicalstructures.

When used to refer to portions of a ventricular or atrial anchor, theterms “proximal” and “distal” refer to locations relative to theattachment point of the anchor to the main body of the frame. The“proximal end” of the anchor is the end closest to the attachment pointof the anchor to the main body. The “distal end” of the anchor is theend farthest away from the attachment point of the anchor to the mainbody when the anchor is fully extended.

The plurality of ventricular anchors 16 can be spaced around thecircumference of the prosthetic valve at about equal intervals. In otherembodiments, the spacing between ventricular anchors is not equal. Insome embodiments, the ventricular anchors can extend radially outwardand upward (toward the annulus), and thus, in certain embodiments, thedistance between distal end portions of adjacent ventricular anchors isgreater than the distance between proximal end portions of theventricular anchors. In various embodiments, the contact between theventricular anchors (which may be covered with a layer of fabric ortissue) and tissue in the vicinity of the native valve annulus (alongthe ventricular side) can also promote tissue in-growth.

By “sandwiching” the native valve annulus from the atrial andventricular sides, the prosthetic valve 10 can move with the nativeannulus in a generally synchronous manner.

Synchronous movement of an implanted prosthetic valve 10 can conferspecific advantages, including faster and/or improvedendothelialization, enhanced in-growth, reduced abrasion of surroundingtissue, and enhanced durability of the prosthetic device. Furthermore,in addition to providing an anchoring means for the prosthetic valve 10,the ventricular anchors 16 can remodel the left ventricle to help treatan underlying cause of mitral regurgitation: left ventricleenlargement/dilation. The ventricular anchors 16 can pull the nativemitral valve leaflets closer together and toward the left atrium and,via the chordae tendineae, thereby pull the papillary muscles closertogether, which can positively remodel the ventricle acutely and preventthe left ventricle from further enlarging. Thus, the ventricular anchors16 can also be referred to as tensioning members or reshaping members.

As used herein, the terms “downward” and “upward” are merely terms ofconvenience. A prosthetic device for implantation in a mitral valveannulus, for example, will be positioned such that a ventricular anchorconfigured to project back toward the atrium and native valve annuluswill thereby be substantially extending “upward.” Likewise, an atrialanchor or other rim portion configured to project in the direction ofthe ventricle will thereby be extending “downward.” In general, becausethe use of the terms “upward” and “downward” are merely conventions,there is no absolute requirement for the ventricular anchor to beoriented substantially or even partially “downward” (relative to theuser, subject or environment) when the device is in use. Except for whenindicated, the positions and orientations of frame components (such asventricular anchors) are described in the expanded configuration.

Additional Frame and Prosthetic Valve Embodiments

FIGS. 3A-3C show three exemplary frame configurations 52 that can beused for the prosthetic valve 10, including manufacturing details andassembly techniques. The frame 52 can comprise a main body 58, an atrialcap 64 and plurality of ventricular anchors 66. The main body 58 cancomprise three (or more) rows of circumferentially-extending, angledstruts 74. The atrial cap 64 can be substantially flat and can comprisea plurality of arms 70 projecting radially outward from points along themain body 58, spaced circumferentially apart around an atrial end 60 ofthe main body.

As shown in FIG. 3A, the ventricular anchors 66 can be manufactured asseparate pieces, and subsequently connected together at a plurality ofconnection locations 82 spaced circumferentially apart around aventricular end 62 of the main body 58. To assemble the frame, aproximal end portion 72 of each ventricular anchor 66 can be broughtinto the vicinity of a connection location 82, and a sleeve 84 (such asa crimp sleeve) can be passed over both the connection location 82 andthe proximal end portion 72. The sleeve 84 can then be compressed (e.g.,crimped) to securely join the proximal end portion 72 to the connectionlocation 82. In addition to or in lieu of the sleeve 84, the anchors 66can be welded to the frame 52 at the connection points 82.

Alternatively, as shown in FIGS. 3B-3C, the frame 52, the atrial arms70, and the plurality of ventricular anchors 66 can be manufactured as asingle unitary structure, such as by laser cutting the frame from ametal tube. The ventricular anchors 66 can then be shape set, such asthrough the use of heat, to produce the requisite conformationalproperties, including having an upward bias.

As shown in FIG. 3B, in some embodiments, the anchors 66 can bemanufactured such that they extend axially away from the main body. A“fold line” L is shown extending through the proximal end portions 72 ofthe anchors 66, which guides shape setting. From this fold line, theanchors 66 can be biased to tum upward toward the frame 52 (as shown inFIGS. 1A and 1B).

In alternative embodiments, as shown in FIG. 3C, the frame 52 can havean extra row of struts 74 (compared to the embodiments shown in FIGS.3A-3B), with the anchors 66 projecting radially outwardly from thebottom row of struts and toward the atrial end of the main body.

FIGS. 4-5 illustrate two exemplary bare frames 102 (in an expandedconfiguration) for use in a prosthetic valve. The frame 102 can comprisea tubular or annular main body 108, an atrial cap 114 extending radiallyoutwardly from an atrial end 110 of the main body 108, and a pluralityof ventricular anchors 116 extending from a ventricular end 112 of themain body 108. When the frame 102 is implanted in the native mitralvalve region of the heart, the main body 108 can be positioned withinthe native mitral valve annulus with the ventricular end 112 of the mainbody 108 being a lower, outlet end, the atrial end 110 of the main body108 being an upper, inlet end, the ventricular anchors 116 being locatedin the left ventricle, and the atrial cap 114 being located in the leftatrium. The embodiments of FIGS. 4 and 5 are similar except for theparticular locations at which the atrial cap 114 connects to the mainbody, as further described below.

The prosthetic valve can comprise a valve structure supported by and/orwithin the frame 102. The valve structure can include a plurality ofprosthetic leaflets and/or other components for regulating the flow ofblood in one direction through the prosthetic valve. For example, valvestructure can be oriented within the frame 102 such that an upper end ofthe valve structure is the inflow end and a lower end of the valvestructure is the outflow end. The leaflets can comprise any of varioussuitable materials, such as natural tissue (e.g., bovine pericardia!tissue) or synthetic materials. The valve structure can be mounted tothe frame 102 using suitable techniques and mechanisms. In someembodiments, leaflets can be sutured to the frame 102 in a tricuspidarrangement. The prosthetic valve can also include a blood-impermeableskirt mounted on the outside and/or the inside of the main body.

Additional details regarding components and assembly of prostheticvalves (including techniques for mounting leaflets to the frame) aredescribed, for example, in U.S. Patent Application Publication No.2009/0276040 A1 and U.S. Patent Publication No. 2010/0217382 A1, whichare incorporated by reference herein.

In an expanded state, as shown in FIGS. 4-5 , the main body 108 of theframe 102 can form an open-ended tube. An outer surface of the main body108 can have dimensions similar to that of the mitral orifice, i.e., theinner surface of the mitral annulus, but not necessarily. In someembodiments, for example, the outer surface of the main body 108 canhave diametrical dimensions that are smaller than the diametricaldimensions of the native mitral orifice, such that the main body 108 canfit within the mitral orifice in the expanded state withoutsubstantially stretching the native mitral annulus. In such embodiments,the frame 102 need not rely on a pressure fit, or friction fit, betweenthe outer surface of the main body 108 and the inner surface of themitral annulus for prosthetic valve retention. Instead, the frame 102can rely on the ventricular anchors 116 and/or the atrial cap 114 forretention. In other embodiments, however, the main body 108 can beconfigured to expand to an equal or greater size than the native mitralorifice and thereby create a pressure fit when implanted, which can becomplementary to the use of ventricular anchors and/or the atrial capfor retention.

The frame 102 can have a wire mesh configuration and can be radiallycollapsible and expandable between a radially expanded state and aradially compressed state to enable delivery and implantation at anatrioventricular valve region of the heart (i.e., at the mitral ortricuspid valve region). The wire mesh can include metal wires or strutsarranged in a lattice pattern, such as a sawtooth or zig-zag pattern,but other patterns may also be used. The frame 102 can comprise ashape-memory material, such as nitinol, to enable self-expansion fromthe radially compressed state to the expanded state. In otherembodiments, the frame 102 can be plastically expandable from a radiallycompressed state to an expanded state by an expansion device, such as aninflatable balloon (not shown), for example. Such plastically expandingframes can comprise stainless steel, chromium alloys, and/or othersuitable materials.

In the illustrated embodiment, the frame 102 comprises a total of twelveventricular anchors 116. In other embodiments, the frame can have afewer or greater number of ventricular anchors, however. The ventricularanchors 116 can each further comprise a proximal or fixed end portion122, an intermediate portion 124 and a distal or free end portion 126.The proximal end portion 122 can be connected directly to theventricular end 112 of the main body 108, and can project downwardly(into the ventricle toward the apex). The intermediate portion 124,located between the proximal end portion 122 and the distal end portion126, can be curved such that the intermediate portion 124 extendsdownwardly from the proximal end portion 122 and then changes directionto extend upwardly toward the mitral valve annulus. The curvedintermediate portion 124 can form between about a quarter-tum and abouta half-tum, such that the curved segment forms an atraumatic surface forcontacting adjacent tissue and structures, such as the chordaetendineae. In some embodiments, the anchors 116 also extend radiallyoutward relative to the main body 108, and thereby project in an angleddirection.

The distal end portion 126 can finally terminate in a curved, atraumatichead portion 128 having a distal end surface 130 for contacting thenative valve annulus. Each distal head portion 128 can comprise a pairof open areas 129 through which tissue can protrude (e.g., tissue on theventricular side of the native valve annulus tissue). Some embodimentsof the head portion have a different shape, for example, a closed shape,a circle, an oval shape, a teardrop shape, a cupped shape, a coil, aspiral, or a serpentine shape. Some embodiments of the frame 102comprise at least one first distal portion with a different shape fromat least one second distal head portion. In some embodiments, the headportion 128 is angled relative to the remainder of the distal endportion 126. For example, as shown in FIGS. 4-5 , the head portions 128can be configured to splay radially outward relative to the rest of thedistal end portions 126. Thus, the angle of the head portion 128,relative to the longitudinal axis of the main body 108, can be greaterthan the angle of the remainder of the distal end portion 126. As shown,the distal end portion 126 comprises an upper section 127 (proximal tothe head portion 128) which splays radially outward, relative to theremainder of the distal end portion 126. In some embodiments, the uppersection 127 is curved. In some embodiments, the head portion 128 splaysradially outward, while the upper section 127 does not splay radiallyoutward.

One or more of the ventricular anchors 116 can be substantially flexible(and/or more flexible than the other anchors 116) and may include apattern of repeating turns 120. FIGS. 4-5 show two such flexibleventricular anchors 116 a positioned adjacent to one another. Otherembodiments include a greater or fewer number of flexible ventricularanchors 116 a. For example, some embodiments include no flexibleventricular anchors, while in other embodiments all of the ventricularanchors are flexible ventricular anchors. A “turn” as used herein canrefer to any curved portion which forms a generally circular path and/orencompasses a complete change in direction. FIGS. 6A-6C show differentconfigurations for a ventricular anchor 116 comprising a pattern ofrepeating turns.

A turn can encompass, for example, a two-dimensional looped coilconfiguration (FIG. 6A), a three-dimensional helical configuration (FIG.6C), or a serpentine configuration (FIGS. 4-5 and 6B). “Serpentine,” asused herein, refers to a configuration in which a series of numeroussegments are connected by curved intermediate portions to form agenerally linear overall arrangement. In some cases, at least one of theanchors has a serpentine configuration comprising a plurality ofsubstantially straight, parallel segments. In some cases, at least oneof the anchors has a serpentine configuration comprising a plurality ofsubstantially curved segments. In some cases, as shown in FIG. 6B, atleast one of the anchors has a serpentine segment comprising both aplurality of substantially straight, parallel segments and a pluralityof substantially curved segments. In other embodiments, a flexibleventricular anchor 116 a comprises a different pattern, for example, azigzag or sinusoidal pattern. Some embodiments of the flexibleventricular anchor comprises a combination of at least one more flexibleportion, for example, a portion comprising a pattern of repeating turns,and at least one less flexible portion, for example, a substantiallystraight portion. Some embodiments comprise a combination of flexibleportions, for example, a serpentine portion and a helical portion.

In various embodiments, the more flexible ventricular anchors 116 a canbe positioned adjacent to sensitive anatomical structures, such asadjacent the ventricular septum in the vicinity of the native mitralvalve annulus. In various embodiments, the more flexible (e.g.,serpentine) anchors can have the same overall shape as the less flexibleventricular anchors, to various extents. For example, while they can beshaped or otherwise biased to curve upward like the other anchors, itmay not be necessary to specifically shape them to splay radiallyoutward, given their flexibility. The possible variations for theventricular anchors 116, for example, length and radial extent, alsoapply to the flexible ventricular anchors.

As shown in FIG. 6B, ventricular anchors 116 having a serpentine shapecan comprise a group of substantially straight, parallel segments 148and/or a group of substantially curved segments 152. The segments 148can be interconnected by curved connecting segments or bends 149. Insome embodiments, the anchors 116 can have straighter portions nearerthe main body 108 (i.e., the proximal end portions 122) and more curvedportions nearer the terminal ends (i.e., the distal end portions 126).In some embodiments, the serpentine shape (such as the parallel segmentsand/or the curved bends) can be thicker at the proximal end portions 122than at the distal end portions 126. Including a serpentine shape in theanchors 116 can decrease their stiffness and/or decrease the chance ofthey will fail due to fatigue. In some embodiments, by increasing thethickness of the serpentine anchors, their flexibility is decreased, andby decreasing their thickness, their flexibility is increased.

Referring again to FIGS. 4-5 , the atrial cap 114 can be integral withthe main body 108 and comprised of the same wire mesh lattice as themain body 108 such that the atrial cap 114 can also be radiallycollapsible and expandable. The atrial cap 114 can also be radiallycollapsible and expandable. The atrial cap 114 can be cut from the sametubing as the main body 108 of the frame 102. In other embodiments, theatrial cap is manufactured as a separate component and subsequentlyattached to the main body, for example, using any of the methodsdescribed above for attaching the ventricular anchors 116 to the mainbody. The atrial cap 114 desirably exhibits sufficient stiffness toprevent the main body 108 from embolizing into the ventricle, but enoughflexibility to avoid or reduce trauma to the native valve anatomy.

In some embodiments, in the expanded state, the atrial cap 114 isgenerally frustoconical. In some embodiments, the atrial cap 114 has acellular structure. In some embodiments, the contact between the atrialcap 114 and the tissue of the atrial walls and/or the atrial face of thenative valve annulus can promote tissue in-growth with the frame, whichcan improve retention and reduce perivalvular leakage. The atrial cap114 is desirably configured to provide a substantially effective sealimmediately on implantation, and thus does not necessarily requiretissue in-growth for effective sealing. Nonetheless, an atrial cap thatrequires tissue in-growth to provide an effective seal may be desirablein certain circumstances, and is encompassed within the scope of thepresent disclosure.

The atrial cap 114 can comprise an integrated structure with an outerrim 140 sized and shaped to contact the atrial side of the mitralannulus and tissue of the left atrium when the frame 102 is implanted.The end plan view profile of the outer rim 140 can have a generallycircular, oval, or other shape (e.g., a D-shape) that generallycorresponds to the native geometry of the atrial wall and the mitralannulus. The outer rim 140 can have a stellate profile comprising apattern of outwardly protruding triangular rim portions 144 extendingaround a circumference of the frame 102 at the atrial end 110.

The rim portions 144 comprise a plurality of angled struts 160 connectedto each other at radial outer junctions or nodes 162 and at radial innerjunctions or nodes 164. The struts 160 can be connected to the main bodyby radially extending struts 146. As shown in FIGS. 4-5 , the struts 146can extend from every other junction 164 of adjacent triangular rimportions 144 to the atrial end 110 of the main body 108. In otherembodiments, the struts 146 and junctions 164 have a differentperiodicity, for example, from 1:3, 1:4, a different ratio, or acombination of ratios. In some cases, as shown in FIG. 4 , the struts146 can be connected to the apices 117 of the angled struts 115 of theuppermost row of struts of the main body at the atrial end 110 of themain body. Alternatively, as shown in FIG. 5 , the struts 146 can beconnected to junctions or nodes 121 at which adjacent angled struts 115from the uppermost row of struts intersect the ends of struts 123 in anadjacent row of struts. Some embodiments include at least one strutconnected to an apex and at least one strut connected to a node.

In the embodiments illustrated in FIGS. 4 and 5 , the body 108 of theframe 102 has a double-body structure, including an annular outerportion overlapping an annular inner portion. In the illustratedembodiments, the atrial cap 114 extends from the outer portion of thebody 108, while the ventricular anchors 116 extend from the innerportion. In other embodiments, the configuration is reversed, with theatrial cap 114 associated with the outer portion and the ventricularanchors 116 with the inner portion; or with both the atrial cap 114 andthe ventricular anchors 116 extending from the same portion; or withanother combination. In the illustrated embodiments, the atrial cap 114and the outer portion are integral; and the ventricular anchors 116 andthe inner portion are integral. As discussed above, in some embodiments,at least some of the ventricular anchors and/or atrial cap portions aremanufactured separately from the body 108 and later attached thereto.

In the illustrated embodiments, the inner and outer portions of the body108 are coextensive and their struts structures mirror each other andcompletely overlap each other. In other embodiments, each of the strutsof the inner and/or outer portion does not have a counterpart in theother portion. The inner and outer portions are attached to each other,for example, by welding, using interlocking tabs, using suture or wire,and/or with pins.

Embodiments of stent bodies 108 having double-body structures permitincreased control over the stent properties, for example, a body withboth stiffer and more flexible portions. In some embodiments, one of theinner portion and outer portion is thicker than the other, resulting inthicker ventricular anchors or a thicker atrial cap. Some embodimentsare better able to withstand mechanical strain during delivery and/orthe cardiac cycle.

FIGS. 7-10 show additional alternative prosthetic valve frameembodiments 202 which comprise a main body 208 (having an atrial end 210and ventricular end 212), ventricular anchors 216, and an atrial cap 214having a plurality of atrial anchors 220. The atrial anchors 220 and theventricular anchors 216 can be spaced angularly apart around thecircumference of the atrial end 210 and ventricular end 212,respectively. In some cases, the atrial anchors 220 and/or theventricular anchors 216 are spaced apart at equal intervals. The atrialanchors 220 in the illustrated embodiment are connected to the main body208 independently of each other, without additional frame segments orstruts interconnecting adjacent atrial anchors 220, allowing the atrialanchors to flex relative to each other and the main body 208. Forpurposes of illustration, only one atrial anchor 220 and one ventricularanchor 216 are shown in the deployed configuration in FIGS. 9-10 . Gaps213 between adjacent atrial anchors 220 accommodate tissue, includingthe mitral valve annulus, the trigones, and the native mitral valveleaflets, as well as permitting the atrial anchors to independentlyadjust to and conform to each patient's particular anatomy.

The atrial anchors 220 can extend generally downwardly from and relativeto the atrial end 210 to contact an atrial side of the native valveannulus and/or tissue of the left atrium. Each anchor 220 can extendfrom an upper row of circumferentially-extending, angled struts 215 atthe atrial end 210. In some embodiments, as shown in FIGS. 7-8 , theanchors 220 extend outward from the apices 217 of the struts 215 at theatrial end 210. In other embodiments, as shown in FIGS. 9-10 , theanchors 220 extend from junctions or nodes 219 at which two adjacentcircumferential struts 218 of the second row (from the atrial end 210)intersect the ends of the struts 215 of the uppermost row of struts.

Each atrial anchor 220 can comprise a proximal or fixed end portion 232connected to the atrial end 210, an intermediate portion 234, and adistal or free end portion 236 that projects radially outwardly from theatrial end 210. The distal end portion 236 can also project downwardlyand/or contact the atrial side of the native valve annulus. The proximalend portion 232 can project upwardly from the atrial end 210, and theintermediate portion 234 can comprise a curved portion (or other type ofbend) that curves upwardly then downwardly to connect to the distal endportion 236. The distal end portion 236 can comprise a terminal portion240 having a head portion 238 at its terminus. The head portion 238 canhave an opening 239 (such as a teardrop shaped opening as shown) throughwhich atrial and/or native valve annulus tissue can protrude whenpressed against the head portion 238 (FIGS. 7-8 ). Other embodiments ofthe head portion have another shape, for example, any of the shapesdiscussed above for the distal head portion 128 of the ventricularanchor. In the illustrated embodiments, an atrial-tissue-contacting faceof the head portion 238 is convex, although in other embodiments, theatrial-tissue-contacting face has another shape, for example,substantially planar, concave, convex, or combinations thereof. In theexpanded configuration, the terminal portion 240 can splay radiallyoutward relative to the remainder of the distal end portion 236.

The atrial anchors 220 can have a flexible and/or serpentineconfiguration, or can be substantially stiff. In various embodiments,one or more atrial anchors 220 can comprise a repeating pattern of turns(e.g., such as shown in FIGS. 8A-8C) to enhance the flexibility of theanchors, which can be positioned adjacent to sensitive anatomicalstructures, such as adjacent to the atrial septum in the vicinity of thenative mitral valve annulus. The atrial anchors 220 and/or the spacesbetween the anchors 220 can be covered by a blood-impermeable fabric ortissue material.

The ventricular anchors 216 can project upward, as described above forframe 102, toward a ventricular side of the native valve annulus (suchas to contact the native valve annulus and/or adjacent tissue). Eachanchor 216 can have a proximal end portion 222 connected to theventricular end 212, an intermediate portion 224 having a bend (such asa curve or angle), and a distal end portion 226. As shown in thedrawings, each proximal end portion 222 can connect to an apex 223defined by the intersection of two adjacent circumferential struts 221of a bottom row of struts of the frame 202 at the ventricular end 212.In alternative embodiments, the proximal end portions 222 of the anchors216 can connect to nodes or junctions 225 defined by where two adjacentcircumferential struts 221 intersect the ends of two struts 218 of a rowimmediately adjacent the lower most row of struts. The ventricularanchors 216 can have distal end portions 226 with atraumatic headportions 228, which may be curved and/or rounded. These head portions228 can each have a teardrop-shaped opening 229 through whichventricular tissue and/or native valve annulus tissue can protrude, orcan have another shape, for example, any of the shapes discussed abovefor the distal head portion 128 of the ventricular anchor.

The terminal ends of the fully deployed ventricular anchors 216 canpoint in a generally upward direction, substantially parallel to thelongitudinal axis of the main body 208. As shown in FIG. 9 , the distalend portions 226 can each have a first section 252 that extends in anangled direction relative to the main body (upward toward the atrial end210 and away from the main body 208) and a second section 254, distal tothe first section 252, that extends more directly upward (toward andgenerally parallel to the longitudinal axis of the main body 208).

The distal end portions 226 can thereby comprise a bend (such as anangled bend as shown in FIG. 9 or a curved bend) between the firstsection 252 and the second section 254. As a result, the ventricularanchors 216 can comprise two bends over the intermediate and distal endportions 224, 226. The two bends of the ventricular anchors 216 can, insome cases, facilitate wrapping of the ventricular anchors 216 aroundthe native leaflets. The second section 254 of the distal end portion226 can comprise the head portion 228 (which can be located at theterminus of the second section 254). In some embodiments, the headportion 228 is configured to extend even more directly upward than therest of the second section 254.

Referring to FIG. 9A, the first section 252 of the distal end portion226 extends toward the atrial end 210 at an angle 260 with respect to aline that is parallel to the longitudinal axis of the frame. Inparticular embodiments, the angle 260 is between about 10 degrees toabout 80 degrees, with about 25 degrees being a specific example. Thesecond section 254 extends at an angle 262 relative to the first section252 in the range of about 100 degrees to about 240 degrees, with about155 degrees being a specific example.

FIG. 10 shows an alternative embodiment of a second section 254, whichis curved to form a rounded (atraumatic) upward-directed surface forcontacting the native valve annulus and/or adjacent tissue. Thisatraumatic portion can be formed by the second section 254 alone, or inconjunction with the head portion 228. Alternatively, the second section254 can be substantially straight (extending in the same direction asthe first segment of the distal end portion 226), and the head portion228 can be curved to form a rounded portion facing the atrial end 210(for example, with a contoured side profile as shown in FIG. 7 ). As inother embodiments, such a curved head portion 228 can have one or moreopenings 229 through which tissue can protrude.

FIGS. 11-12 show a top perspective view and a bottom perspective view ofanother exemplary prosthetic valve frame 302 comprising a main body 308,an atrial cap 314 extending radially outward from an atrial end 310 ofthe main body 308, and a plurality of ventricular anchors 316 extendingfrom a ventricular end 312 of the main body 308. The atrial cap 314 cancomprise a stellate pattern, similar to as described above for frame102. In this embodiment, as shown, the triangular frame elements do notextend uniformly around the circumference of the atrial end 310. Rather,the atrial cap 314 can comprise discrete groups 340 of triangular rimportions 344 that are not directly connected to each other withinterconnecting struts.

FIGS. 11-12 show an embodiment having three groups 340 of six triangularrim portions 344. The groups 340 can be spaced angularly apart aroundthe circumference of the atrial end 310. The atrial cap 314 can haveopen areas 342 in between the groups 340 where there are no triangularrim portions 344 or other atrial cap elements. Each group 340 can havefour struts 346, which can be spaced equally apart, connecting thetriangular portions 344 to the atrial end 310. In particular, the struts346 can be connected to apices 317 along a first row of circumferentialstruts 315 at the atrial end 310. For each group 340, the struts 346 canextend from the main body 308 to the peripheral edges of the outermosttriangular portions 344, and from the main body 308 to every otherjunction 348 of adjacent triangular rim portions 344 (starting from theouter edges of the outermost triangular rim portions). The ventricularanchors 316 can be shaped and configured similar to as described abovefor frame 202. Other embodiments independently include greater or fewerthan three groups of rim portions 344, greater or fewer than four struts346 per group 340 of rim portions, and or struts that are spacedunequally.

FIGS. 13-14 show top views of two additional prosthetic valveembodiments 400, each having an atrial cap member 414 with radiallyextending arm-like atrial anchors or struts 418. Each arm-like strut 418extends radially outward from an originating rim portion 438 to an outerrim portion 440. In some cases, as shown in FIG. 13 , the struts 418each have a flexible, serpentine configuration (such as also shown inFIG. 8B). The prosthetic valves 400 can each have at least one layer offabric or other biocompatible material 412 extending between pairs ofstruts and covering the terminal portions of each strut 418. In someembodiments, the material layer 412 covers the struts 418 themselves.

In some cases, the distribution and/or composition of the struts 418 issymmetrical (FIG. 13 ). In some embodiments, the composition of thestruts 418 is asymmetrical and can include one or more relatively moreflexible struts 418 a and one or more less flexible struts 418 b. Asshown in FIG. 14 , the more flexible or distensible struts 418 a can beconcentrated in one area. For example, the struts which face the atrialseptum and/or abutting other sensitive structures (native or foreign)can be more flexible and/or more distensible relative to the otherstruts. In alternative embodiments, the struts 418 can have any ofconfigurations described above for the ventricular anchors in connectionwith FIGS. 8A-8C.

Delivery Techniques and Assemblies

In some cases, for safety and/or other reasons, the disclosed prostheticdevices may be delivered from the atrial side of the atrioventricularvalve annulus. Delivery from the atrial side of the native valve annuluscan be accomplished in various manners. For example, a transatrialapproach can be made through an atrial wall, which can be accessed, forexample, by an incision through the chest. Atrial delivery can also bemade intravascularly, such as from a pulmonary vein. The prostheticvalve can be delivered to the right atrium via the inferior or superiorvena cava. In some cases, left atrial delivery can be made via atranseptal approach (FIGS. 16A-16D). In a transeptal approach, anincision can be made in the atrial portion of the septum to allow accessto the left atrium from the right atrium. The prosthetic valve can alsobe delivered via transventricular (FIG. 19 ), transatrial (FIG. 17 ), ortransfemoral (FIG. 18 ) approaches with small or minimal modificationsto the delivery process.

To deliver the prosthetic valve to the native mitral valve annulus, theprosthetic valve can be radially crimped into a collapsed configurationwithin a sheath of a delivery catheter. Delivery and placement of theprosthetic valve can be angularly independent, such that the prostheticvalve does not require any special rotational alignment relative to theaxis of the prosthetic valve. Thus, during delivery, the prostheticvalve may not require any special rotational placement so as to alignthe ventricular anchors with particular anatomical landmarks (such asthe native valve leaflets, particular portions thereof, native valvecommissures, chordae tendineae, and/or location of the aortic valve).

While in certain embodiments, the prosthetic valve is positioned suchthat certain atrial and/or ventricular arms or anchors face sensitivestructures (such as the atrial or ventricular septum), this positioningcan be approximate and may not necessarily require precise rotationalalignment. Thus, such a positioning will generally not require the userto exert a considerable effort achieving a particular rotationalalignment for the valve.

In some embodiments, the prosthetic valve can fit inside of a 30 French(F) catheter (in a collapsed state). In some embodiments, the prostheticvalve can be configured to fit into even smaller catheters, such as a 29F, 28 F, 27 F, or 26 F catheter.

FIGS. 15A-15C show an exemplary prosthetic valve delivery assembly,including the process of expanding the prosthetic valve using a sheath,with reference to an embodiment of the prosthetic valve using the frameillustrated in FIG. 4 , although the delivery assembly and method areapplicable to each of the frame embodiments disclosed herein. In thedelivery configuration (FIG. 15A), a retractable sheath 502 of adelivery catheter 500 can be advanced over the collapsed prostheticvalve, with the main body 108, atrial cap 114 (not shown) andventricular anchors 116 all in a radially collapsed configuration. Theventricular anchors 116 can be contained within the sheath 502 in asubstantially linear arrangement, distal to the main body 108, such thatthe distal end portions 126 are axially aligned with the intermediateportions 124 and the proximal end portions 122. Thus, while the distalend portions 126 may be biased to extend upward (in the direction of themain body 108) when deployed, the constraining or restraining forceapplied by the sheath 502 on the anchors 116 can force the distal endportions 126 to extend downward (away from the main body 108 in agenerally apical direction) during delivery.

Once the prosthetic valve 100 is delivered to the native annulus region,the sheath 502 can be retracted relative to the prosthetic valve 100,thereby allowing the prosthetic valve 100 to expand radially outward.The release of the prosthetic valve 100 can be conducted in stages. Inparticular, the ventricular anchors 116 can be released from the sheath502 (FIG. 15B) prior to the release of the main body 108 (FIG. 15C). Asshown in FIG. 15B, when the ventricular anchors 116 are released, theanchors 116 can spread out away from the main body 108, with distal endportions 126 directed radially outward and upward. Then, with release ofthe main body, the anchors 116 can rotate toward the main body 108, suchthat the distal end portions 126 can pivot toward the vertical(longitudinal) axis and wrap around the native leaflets.

FIGS. 16A-16D show the process of delivering the prosthetic valveassembly to the native mitral valve annulus, according to oneembodiment. FIG. 16A shows the catheter 500 (carrying the prostheticvalve 100 within the sheath 502 at its distal end) introduced into theright atrium of the heart, then across the atrial septum and into theleft atrium. The catheter 500 can be further advanced such that thesheath 502 (carrying the prosthetic valve) extends between the nativeleaflets of the mitral valve and into the left ventricle. At this point,the prosthetic valve 100 can be advanced out of the distal end of thesheath 502, such as by advancing a pusher device distally against theprosthetic valve and/or retracting the sheath 502 relative to theprosthetic valve 100, resulting in the deployment of the ventricularanchors 116 (FIG. 16B).

As shown in FIG. 16B, the deployed ventricular anchors 116 can extendradially outwardly behind the native leaflets 602. The surgeon or otheruser can then optionally reposition the partially retracted valve 100 asdesired, then retract the sheath 502 further to cause the ventricularanchors 116 to engage the native valve annulus (FIG. 16C). Inparticular, the anchors 116 can be configured to point more directlyupward upon full deployment, as compared to when they are partiallydeployed from the sheath 502. At this point, the user can assessengagement of the ventricular anchors 116 with the native valve annulus(such as through imaging means), prior to retracting the sheath 502further to deploy the main body 108 and the atrial cap 114 (FIG. 16D).As shown in FIGS. 16C-16D, the ventricular anchors 116 can progressivelypivot with deployment of the main body 108, such that the distal endportions 126 pivot or rotate to point more directly upward.

The head portions 128 of the upward directed distal end portions 126 cancontact a ventricular side of the native valve annulus and/or adjacenttissue (such as trigone areas) (FIG. 16D). In some cases, however, atleast one of the ventricular anchors 116 does not reach the native valveannulus or adjacent tissue, but can nonetheless produce stable placementof the prosthetic valve 100. For example, in some cases, the at leastone ventricular anchor 116 can produce this stable placement at thenative valve annulus region by engaging the chordae tendineae below thenative valve annulus.

In some implementations, one or more ventricular anchors 116 engage thechordae tendineae, one or more ventricular anchors engage the trigoneareas, and/or one or more ventricular anchors engage the native leafletsat A2 and/or P2 positions (i.e., between the commissure of the nativeleaflets). The ventricular anchors that engage the native leaflets andthe trigone areas can capture or “sandwich” the native tissue betweenthe outer surface of the main body of the prosthetic valve and theventricular anchors (or portions thereof) such that the tissue iscompressed and engaged by the main body of the prosthetic valve on oneside and by the ventricular anchors on the other side. In someembodiments, due to the capturing of the native tissue (such as thenative leaflets) between the ventricular anchors and the main body, thenative tissue forms a seal around the main body (through 360 degrees)within the left ventricle that impedes blood from traveling along theoutside of the main body (as best shown in FIG. 20 ). In someembodiments, tissue is also or alternatively sandwiched between theatrial cap 114 and ventricular anchors 116. By virtue of theirrelatively thin profile and because the ventricular anchors are notinterconnected to each other, the distal ends of the ventricular anchorsadjacent the chordae tendineae can pass between individual chordsextending from the native leaflets, allowing those anchors to flex/pivotupwardly and assume their fully deployed positions.

Finally, as shown in FIG. 16D, the sheath 502 can be retracted furtherto release the atrial cap 114. The atrial cap 114 forms a seal againstthe native annulus within the left atrium. The seal created in the leftatrium by the atrial cap 114 and the seal created by the ventricularanchors 116 in the left ventricle together prevent, reduce, or minimizethe flow of blood between the native annulus and the outside of the mainbody 108 during diastole and systole. In some embodiments, the main body108 and the atrial cap 114 are released simultaneously, while in otherembodiments, the main body 108 is released prior to the atrial cap 114.Upon full deployment of the ventricular anchors 116 and the main body108, the distal end portions 126 can be positioned against the nativevalve annulus and/or adjacent tissue (e.g., trigone areas). All stagesof deployment of the prosthetic valve 100 can thus be controlled by thecatheter 500 without additional activation or manipulation necessary. Incertain embodiments, however, the prosthetic valve 100 and/or thecatheter 500 can comprise a switch or other control to regulate therelease and/or subsequent movement of ventricular anchors 116 or themain body 108.

In alternative embodiments, the prosthetic valve 100 can be delivered tothe native mitral valve via the left ventricle (FIGS. 18-19 ). FIGS.18-19 illustrate deliveries and deployments of embodiments of prostheticvalves incorporating the frame illustrated in FIGS. 7 and 8 , but theassemblies and methods are applicable to prosthetic valves including anyof the frames disclosed herein. In a transventricular approach (FIG. 19), for example, the delivery catheter 500 can be inserted into the leftventricle through a surgical incision made at or near the bare spot onthe lower anterior ventricle wall. In this approach and in thetransfemoral approach (FIG. 18 ), the prosthetic valve 100 can be loadedinto the sheath 502 in the reverse position such that the atrial cap 214is closest to the distal end of the sheath. During implantation, theatrial cap 214 can be deployed first, followed by the main body 208(FIGS. 7-8 ) and the ventricular anchors 216.

In various embodiments, portions of the prosthetic valve 100 can bepartially or fully recaptured during the delivery process entirelythrough manipulation of the sheath 502. The ability to recapture theprosthetic valve 100 can be advantageous, for example, in case of damageto the prosthetic valve 100 during delivery and/or in case of operatorerror in placement of the prosthetic valve 100. In some embodiments, theventricular anchors 116 can be recaptured following release from thesheath 502, simply by advancing the sheath 502 over the deployed anchors116, thereby bringing the anchors 116 back into a linear configurationwithin the confines of the sheath 502. In some embodiments, the mainbody 108 can also be recaptured, also by advancing the sheath 502 overthe deployed body 108.

Some embodiments of the delivery system include an inner sheath, locatedwithin the sheath 502, which contains the main body 108 and the atrialcap 114 but does not contain the ventricular anchors 116. In this case,the sheath 502 can be fully retracted to release the ventricular anchors116, with release of the main body 108 and atrial cap 114 controlled byretraction of the inner sheath.

FIG. 21 is a side elevation view of another prosthetic valve frame 702that can be implemented in a prosthetic valve. The frame 702 comprisesan annular main body 708, an atrial cap 714 extending radially outwardfrom the atrial end 710 of the main body, and a plurality of ventricularanchors 716 extending from the ventricular end 712 of the main body. Theatrial cap 714 can comprise a continuous annular rim 718 formed from aplurality of circumferentially extending angled struts 720. The atrialcap 714 can comprise a plurality of radially extending connecting struts722. Each connecting strut 722 has a first end connected to an apex 724of two struts 720 and a second end connected to an apex 726 of twoangled struts 728 of the main body 708.

As can be seen in FIG. 21 , the second ends of the connecting struts 722are connected to the apices 726 of struts 728 that form a row ofcircumferentially extending struts adjacent the uppermost row of struts730 that form the atrial end 710 of the main body. In this manner, whenthe frame 702 is deployed from a delivery sheath, the atrial cap 714curls or deflects downwardly below the atrial end 710 toward theventricular end 712, which assists in pushing the prosthetic valvefurther upwardly into the left atrium to minimize obstruction of theleft ventricular outflow tract (LVOT). In particular embodiments, theentire atrial cap 714 is spaced below the atrial end 710 of the mainbody 708. In alternative embodiments, the connecting struts 722 can beconnected to the apices of struts 730 that form the atrial end 710 ofthe main body 708.

The main body 708 can have an overall tapered shape defining an inletdiameter D1 at the atrial end 710 and a smaller outlet diameter D2 atthe ventricular end 712. In the illustrated embodiment, the main body708 comprises a first, substantially cylindrically-shaped inlet portion732 defining the inlet diameter and a second, conically-shaped outletportion 734 defining the outlet diameter, which tapers in a directionextending from the lower end of the inlet portion 732 toward theventricular end 712 of the main body. The inlet end portion 732 can berelatively large and oversized relative to the native mitral valveannulus to establish a good seal between the outer surface of theprosthetic valve and the native leaflets 602 to prevent or minimizeparavalvular leakage while the relatively smaller outlet end portion 734prevents or minimizes obstruction of the LVOT. In certain embodiments,the inlet diameter D1 of the inlet end portion 732 is at least about 30mm to about 50 mm, with about 40 mm being a specific example, while theoutlet diameter D2 of the outlet end portion 732 is about 20 to about40, with about 30 mm being a specific example.

Each ventricular anchor 716 can have a fixed end portion 736 connectedto the ventricular end 712 of the main body, an intermediate portion 738having a bend, and a free end portion 740. As shown in the drawings,each fixed end portion 736 can be connected to an apex 742 formed by twoangled struts at the ventricular end 712 of the main body. The free endportions 740 can have atraumatic head portions 744, which may be curvedand/or rounded. The head portions 744 can each have a teardrop-shapedopening through which ventricular tissue and/or native valve annulustissue can protrude, or can have another shape, for example, any of theshapes discussed above for the distal head portion 128 of theventricular anchor.

The ventricular anchors 716 are relatively wide and stiff in the lateraldirection to minimize side-to-side movement of the anchors to permitcrimping and deployment without the anchors becoming entangled with eachother. To minimize axial stiffness (to facilitate crimping anddeployment), the thickness of the intermediate portions 738 can bereduced relative to other portions of the anchors 716 and the main body708. In certain embodiments, for example, the intermediate portions 738can be thinner than the fixed end portions 736, the free end portions740, and the main body 708.

FIGS. 22 and 23 show one technique for forming a frame 702 withventricular anchors 716 having a reduced thickness. FIG. 22 shows ametal tube 750 (e.g., a Nitinol tube) for forming the frame 702. Thetube 750 is treated by, for example, machining, grinding, orelectro-polishing, to produce a recessed portion 752 having a reducedthickness relative to the remainder of the tube 750. FIG. 23 shows thepattern for laser cutting the frame 702 from the tube 750. As can beseen, the intermediate portions 738 are formed from the recessed portion752 of the tube such that the finished frame (fully cut from the tube)is thinner along the intermediate portions 738 compared to the remainderof the frame.

FIG. 24 shows a cross-section of a ventricular anchor 716 taken throughthe intermediate portion 738. In certain embodiments, the anchors 716have width W of about 0.8 mm to about 2.0 mm, with about 1.4 mm being aspecific example. The width W can be constant along the entire length ofthe anchor. In certain embodiments, the intermediate portions 738 of theanchors have a thickness T of about 0.4 mm and the remainder of theframe 702 (including the fixed end portions 736 and the free endportions 740 of the anchors) can have a thickness of about 0.5 mm.

FIG. 25 is a side elevation view of another prosthetic valve frame 802that can be implemented in a prosthetic valve. FIG. 26 shows the frame802 covered by an outer skirt or sealing member 846. The frame 802comprises an annular main body 808, an atrial cap 814 extending radiallyoutward from the atrial end 810 of the main body, and a plurality ofventricular anchors 816 extending from the main body at a locationproximate the ventricular end 812 of the main body. The atrial cap 814can comprise a continuous annular rim 818 formed from a plurality ofcircumferentially extending angled struts 820. The atrial cap 814 cancomprise a plurality of radially extending connecting struts 822. Eachconnecting strut 822 has a first end connected to an apex 824 of twostruts 820 and a second end connected to an apex 826 of two angledstruts 828 of the main body 808, spaced from the atrial end 810 of themain body. In alternative embodiments, the connecting struts 822 can beconnected to the apices at the atrial end 810 of the main body.

The main body 808 can have an overall tapered or conical shape definingan inlet diameter D1 at the atrial end 810 and a smaller outlet diameterD2 at the ventricular end 812. In certain embodiments, the inletdiameter D1 is at least about 30 mm to about 50 mm, with about 40 mmbeing a specific example, while the outlet diameter D2 is about 20 toabout 40, with about 30 mm being a specific example.

Each ventricular anchor 816 can have a fixed end portion 836 connectedto the main body, an intermediate portion 838 having a bend, and a freeend portion 840. As shown in the drawings, each fixed end portion 836can be connected to an apex 842 formed by two angled struts 828 forminga row of struts spaced from the ventricular end 812 of the main body.

Mounting the ventricular anchors 816 at a location closer toward theatrial end reduces the distance between atrial cap 814 and theventricular anchors to enhance anchoring of the prosthetic valve. Inaddition, the ventricular anchor 816, being spaced from the ventricularend 812 of the main body, are mounted to a relatively stiff region ofthe frame to minimize distortion of the frame during crimping anddeployment. In alternative embodiments, the ventricular anchors 816 canbe connected to the apices at the ventricular end 812 of the main body.

The free end portions 840 of the ventricular anchors can have atraumatichead portions 844, which may be curved and/or rounded. The head portions844 can each have a teardrop-shaped opening through which ventriculartissue and/or native valve annulus tissue can protrude, or can haveanother shape, for example, any of the shapes discussed above for thedistal head portion 128 of the ventricular anchor.

As best shown in FIG. 27 , the fixed end portion 836 of each ventricularanchor 816 can be tapered such that the fixed end portion is reduced inwidth W where it is connected to an apex 842 to enhance flexibility ofthe connection between the anchors and the main body. The intermediateportion 838 of each anchor can have a reduced thickness T relative toother portions of the anchors 816 and the main body 808 to minimizeaxial stiffness of the anchors.

General Considerations

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, devices, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, devices, and systems are not limited to anyspecific aspect or feature or combination thereof, nor do the disclosedembodiments require that any one or more specific advantages be presentor problems be solved.

Features, integers, characteristics, compounds, chemical moieties orgroups described in conjunction with a particular aspect, embodiment orexample of the invention are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations where at least some of suchfeatures and/or steps are mutually exclusive. The invention is notrestricted to the details of any foregoing embodiments. The inventionextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods. Asused herein, the terms “a”, “an”, and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A”,“B”, “C”, “A and B”, “A and C”, “BandC”, or “A, B, and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is at least as broad as the following exemplaryclaims. We therefore claim at least all that comes within the scope ofthe following claims.

1. A method of implanting a prosthetic heart valve at a native tricuspidvalve region having a native valve annulus and a plurality of nativeleaflets, comprising: delivering a prosthetic heart valve to the nativetricuspid valve region via the inferior vena cava or the superior venacava, the prosthetic heart valve contained within an interior of asheath of a delivery apparatus, the prosthetic heart valve comprising: aradially compressible and expandable frame assembly comprising an inflowend, an outflow end, and a double-body structure having an annular innerframe and an annular outer frame, the inner frame having a main bodycomprising a plurality of circumferentially extending rows of angledstruts and the annular outer frame having a main body and an atrialflange portion configured to contact an atrial face of the native valveannulus; a plurality of prosthetic leaflets mounted within the innerframe for regulating the flow of blood in one direction through theinner frame; and a plurality of ventricular anchors, each comprising afree end portion and a fixed end portion connected to and extending fromthe frame assembly at a location spaced from the outflow end of theframe assembly; and deploying the prosthetic heart valve from the sheathsuch that the main bodies of the inner and outer frames expand withinthe native annulus, the atrial flange portion is deployed in an atriumadjacent the native annulus, and each of the plurality of ventricularanchors extend behind one of the native leaflets.
 2. The method of claim1, wherein the plurality of ventricular anchors are asymmetricallyarranged around the frame.
 3. The method of claim 1, wherein theplurality of ventricular anchors are unevenly spaced around acircumference of the frame.
 4. The method of claim 1, wherein theplurality of ventricular anchors are separately formed and connected tothe frame assembly.
 5. The method of claim 1, wherein each of theplurality of ventricular anchors has a serpentine shape.
 6. The methodof claim 1, wherein the free end portion of each of the plurality ofventricular anchors comprises a curved head portion.
 7. The method ofclaim 1, wherein the fixed end portion of each of the plurality ofventricular anchors extends in a downward direction.
 8. The method ofclaim 1, wherein the free end portion of each of the plurality ofventricular anchors extends in an upward direction.
 9. The method ofclaim 1, wherein each plurality of ventricular anchors is connected tothe main body independently of each other without frame segmentsinterconnecting adjacent ventricular anchors.
 10. A method of implantinga prosthetic heart valve at a native tricuspid valve region having anative valve annulus and a plurality of native leaflets, comprising:delivering a prosthetic heart valve to the native tricuspid valve regionvia the inferior vena cava or the superior vena cava, the prostheticheart valve contained within an interior of a sheath of a deliveryapparatus, the prosthetic heart valve comprising: a radiallycompressible and expandable frame assembly comprising an inflow end andan outflow end; a plurality of prosthetic leaflets mounted within theframe assembly for regulating the flow of blood in one direction throughthe frame assembly; an atrial flange portion extending from the frameassembly, wherein the atrial flange portion comprises a plurality ofangularly spaced atrial anchors and is configured to contact an atrialface of the native valve annulus; and a plurality of ventricularanchors, each comprising a free end portion and a fixed end portionconnected to and extending from the frame assembly at a location spacedfrom the outflow end of the frame assembly; and deploying the prostheticheart valve from the sheath such that the frame assembly expands withinthe native annulus, the atrial flange portion is deployed in an atriumadjacent the native annulus, and each of the plurality of ventricularanchors extend behind one of the native leaflets.
 11. The method ofclaim 10, wherein an outer rim of the atrial flange portion has an ovalshape.
 12. The method of claim 10, wherein a first one of the pluralityof atrial anchors has a first length and a second one of the pluralityof atrial anchors has a second, different length.
 13. The method ofclaim 10, wherein each of the plurality of atrial anchors extends fromthe frame assembly at a location spaced from the inflow end of the frameassembly.
 14. The method of claim 10, wherein each of the plurality ofatrial anchors is independently coupled to the frame assembly withoutframe segments interconnecting adjacent atrial anchors.
 15. The methodof claim 10, wherein each of the plurality of atrial anchors comprises ateardrop-shaped opening.
 16. The method of claim 10, further comprisinga fabric layer extending over the atrial flange portion.
 17. A method ofimplanting a prosthetic heart valve at a native tricuspid valve regionhaving a native valve annulus and a plurality of native leaflets,comprising: delivering a prosthetic heart valve to the native tricuspidvalve region via the superior vena cava, the prosthetic heart valvecontained within an interior of a sheath of a delivery apparatus, theprosthetic heart valve comprising: a radially compressible andexpandable frame assembly comprising an inflow end, an outflow end, anda double-body structure having a annular inner frame coupled to anannular outer frame, the inner frame comprising a main body and theouter frame comprising a main body and an atrial flange portion, whereinthe inner and outer frames are separately formed and coupled to eachother with suture or wire; a plurality of prosthetic leaflets mountedwithin the main body of the inner frame for regulating the flow of bloodin one direction through the main body; and a plurality of ventricularanchors, each comprising a free end portion and a fixed end portionconnected to and extending from the frame assembly at a location spacedfrom the outflow end of the frame assembly; and deploying the prostheticheart valve from the sheath such that the main bodies of the inner andouter frames expand within the native annulus, the atrial flange portionis deployed in an atrium adjacent the native annulus, and each of theplurality of ventricular anchors extend behind one of the nativeleaflets.
 18. The method of claim 17, wherein each of the ventricularanchors has a serpentine shape.
 19. The method of claim 17, wherein theframe assembly is self-expandable when deployed from the sheath.
 20. Themethod of claim 17, wherein the inner frame further comprises aplurality of axially extending tabs, wherein each tab extends axiallyfrom an apex formed by the intersection of adjacent angled struts at anend of the inner frame.